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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device full field digital, system, x-ray, mammographic
Product CodeMUE
Regulation Number 892.1715
Device Class 2


Premarket Reviews
ManufacturerDecision
ADANI
  SUBSTANTIALLY EQUIVALENT 1
AGFA HEALTHCARE N.V.
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH,INC.
  SUBSTANTIALLY EQUIVALENT 1
DRTECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 2
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM MEDICAL SYSTEMS, USA INC.
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 9
GE MEDICAL SYSTEMS SCS
  SUBSTANTIALLY EQUIVALENT 1
GENERAL ELECTRIC COMPANY
  SUBSTANTIALLY EQUIVALENT 2
GIOTTO USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICRCO INC.
  SUBSTANTIALLY EQUIVALENT 1
IMS GIOTTO S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
METALTRONICA SPA
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB
  SUBSTANTIALLY EQUIVALENT 3
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
PLANMECA USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
PLANMED OY
  SUBSTANTIALLY EQUIVALENT 4
RAYENCE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SECTRA IMTEC AB
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 5
SIEMENS MEDICAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VMI TECNOLOGIAS LTDA
  SUBSTANTIALLY EQUIVALENT 1

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
8 10 0 0 0 0 0 0 0 0 0 0 0 0 0 0

MDR Year MDR Reports MDR Events
2014 7 7
2015 5 5
2016 19 19
2017 115 115
2018 144 144
2019 80 80
2020 49 49
2021 25 25
2022 36 36
2023 29 29
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 155 155
Device Operational Issue 108 108
Device Displays Incorrect Message 54 54
Poor Quality Image 36 36
Device Operates Differently Than Expected 34 34
Unintended Movement 23 23
Break 17 17
Use of Device Problem 15 15
Adverse Event Without Identified Device or Use Problem 13 13
Mechanical Problem 9 9
Device Stops Intermittently 8 8
Insufficient Information 5 5
Improper or Incorrect Procedure or Method 5 5
Detachment of Device or Device Component 3 3
Positioning Problem 3 3
Unintended Collision 3 3
Shielding Failure 3 3
Collapse 3 3
Detachment Of Device Component 3 3
Component Falling 2 2
Computer Software Problem 2 2
Crack 2 2
Display or Visual Feedback Problem 2 2
Material Fragmentation 2 2
Image Display Error/Artifact 2 2
Imprecision 2 2
Device Slipped 2 2
Structural Problem 2 2
Device Emits Odor 2 2
Power Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Maintenance Does Not Comply To Manufacturers Recommendations 2 2
No Apparent Adverse Event 2 2
Patient Data Problem 2 2
Noise, Audible 2 2
Physical Resistance/Sticking 2 2
Calibration Problem 2 2
Physical Property Issue 2 2
Communication or Transmission Problem 1 1
Connection Problem 1 1
Device Issue 1 1
Wrinkled 1 1
Application Program Problem 1 1
Device Dislodged or Dislocated 1 1
Electrical Shorting 1 1
Flare or Flash 1 1
Human Factors Issue 1 1
Human-Device Interface Problem 1 1
Improper Device Output 1 1
Device Contaminated During Manufacture or Shipping 1 1
Unintended Electrical Shock 1 1
Device Handling Problem 1 1
Appropriate Term/Code Not Available 1 1
Material Integrity Problem 1 1
Mechanical Jam 1 1
Naturally Worn 1 1
Operating System Becomes Nonfunctional 1 1
Output Problem 1 1
Device Abrasion From Instrument Or Another Object 1 1
Failure to Power Up 1 1
Product Quality Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Retraction Problem 1 1
Failure To Service 1 1
Failure to Disconnect 1 1
Defective Device 1 1
Device Tipped Over 1 1
Smoking 1 1
Labelling, Instructions for Use or Training Problem 1 1
Material Erosion 1 1
Fire 1 1
Fracture 1 1
Material Disintegration 1 1
Erratic or Intermittent Display 1 1
Thermal Decomposition of Device 1 1
Device Alarm System 1 1
Unintended Arm Motion 1 1
Signal Artifact/Noise 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Not Applicable 138 138
No Consequences Or Impact To Patient 105 105
Radiation Exposure, Unintended 92 92
No Clinical Signs, Symptoms or Conditions 84 84
No Known Impact Or Consequence To Patient 33 33
Pain 10 10
No Code Available 8 8
Insufficient Information 5 5
No Information 5 5
Fall 4 4
Bone Fracture(s) 3 3
Bruise/Contusion 3 3
Laceration(s) 3 3
Misdiagnosis 3 3
No Patient Involvement 3 3
Patient Problem/Medical Problem 3 3
Injury 3 3
Fracture, Arm 2 2
Electric Shock 2 2
Hematoma 2 2
Irritation 1 1
Itching Sensation 1 1
Cardiac Arrest 1 1
Contusion 1 1
Radiation Overdose 1 1
Syncope 1 1
Tingling 1 1
Dizziness 1 1
Muscle Spasm(s) 1 1
Loss of Range of Motion 1 1
Skin Irritation 1 1
Sprain 1 1
Burning Sensation 1 1
Full thickness (Third Degree) Burn 1 1
Reaction 1 1
Sensitivity of Teeth 1 1
Skin Tears 1 1
Rupture 1 1
Anxiety 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Muscle/Tendon Damage 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beekley Corporation III Jun-13-2014
2 Fujifilm Medical System USA, Inc. II May-21-2014
3 Fujifilm Medical Systems U.S.A., Inc. II Feb-20-2018
4 Fujifilm Medical Systems U.S.A., Inc. II Jan-17-2018
5 Fujifilm Medical Systems U.S.A., Inc. II Aug-30-2016
6 Fujifilm Medical Systems U.S.A., Inc. II May-06-2015
7 GE Healthcare, LLC II Jul-30-2019
8 GE Healthcare, LLC II Jun-26-2013
9 GE Healthcare, LLC II Feb-20-2012
10 GE Healthcare, LLC II Oct-26-2011
11 GE Healthcare, LLC II Mar-18-2011
12 GE Healthcare, LLC II Mar-17-2011
13 GE Medical Systems, SCS II Feb-08-2024
14 Hologic, Inc. II Feb-18-2020
15 Hologic, Inc. II Dec-27-2018
16 Hologic, Inc. II Jun-03-2014
17 Hologic, Inc. II Sep-30-2013
18 Siemens Medical Solutions USA, Inc II Jun-16-2020
19 Siemens Medical Solutions USA, Inc II Oct-18-2019
20 Siemens Medical Solutions USA, Inc II Jan-31-2017
21 Siemens Medical Solutions USA, Inc II Dec-06-2014
22 Siemens Medical Solutions USA, Inc II Oct-17-2014
23 Siemens Medical Solutions USA, Inc II May-20-2014
24 Siemens Medical Solutions USA, Inc II Jul-11-2013
25 Siemens Medical Solutions USA, Inc II Jan-11-2012
26 Siemens Medical Solutions USA, Inc II May-07-2009
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